NCT07027917

Brief Summary

The aim of this study is to examine the effects of virtual reality glasses applied to individuals who will undergo pleural catheter placement on pain, anxiety, and vital parameters. The main research questions that the study aims to answer are as follows:

  • Does the application of virtual reality goggles have an effect on pain measured during pleural catheter insertion?
  • Does the application of virtual reality goggles have an effect on anxiety measured during pleural catheter insertion?
  • Does the application of virtual reality goggles have an effect on the vital parameters measured during pleural catheter insertion? The researcher compared the intervention and control groups to determine whether the glasses have an effect on the measurable parameters (pain, anxiety, and vital signs).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 19, 2025

Completed
Last Updated

June 19, 2025

Status Verified

June 1, 2025

Enrollment Period

Same day

First QC Date

February 20, 2025

Last Update Submit

June 17, 2025

Conditions

Keywords

painanxietynursingpleural cathetervirtual realityvital signsstate anxietyVASVR

Outcome Measures

Primary Outcomes (1)

  • Pain severity

    Pain severity will be assessed using the Visual Analog Scale (VAS), a 10 cm scale ranging from 0 (no pain) to 10 (worst possible pain), measurements will be taken before, during and after pleural catheter insertion.

    From immediately before to 10 minutes after catheter insertion

Secondary Outcomes (1)

  • Anxiety level

    From immediately before to 10 minutes after catheter insertion

Study Arms (2)

Virtual Reality Goggles During Catheterization

EXPERIMENTAL

In this group, virtual reality glasses were applied during the pleural catheter insertion procedure.

Device: Virtual Reality Goggles

Standard Catheterization Without VR

NO INTERVENTION

No additional intervention was applied to this group other than the routine catheter insertion procedure.

Interventions

VR

Virtual Reality Goggles During Catheterization

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written or verbal consent to participate, Being over 18 years of age, Not having any psychiatric diagnosis, Not having any problems with vision, hearing, perception or communication.

You may not qualify if:

  • Being unconscious Experiencing pain due to any other problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aydın Adnan Menderes Üniversitesi

Aydin, Merkez, 09010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Uzman hemşire, Adnan Menderes Üniversitesi, Cerrahi Hastalıkları Hemşireliği Anabilim Dalı

Study Record Dates

First Submitted

February 20, 2025

First Posted

June 19, 2025

Study Start

November 30, 2023

Primary Completion

November 30, 2023

Study Completion

June 12, 2024

Last Updated

June 19, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

Locations